The FDA smacked Novo Nordisk, producer of blockbuster weight loss drug semaglutide, the active ingredient in Wegovy and Ozempic, for quality control deficiencies discovered at its Clayton, N.C., plant, including…

Companies selling unapproved biologics products is a major ongoing concern for the FDA’s CBER, says an agency consumer safety expert, speaking at the 2023 PDA/FDA Joint Regulatory Conference on Wednesday.…

Medline Industries’ recall of 18,000 saline solution vials due to being non-sterile has been deemed as class 1 by the FDA, the most serious type of recall, because use of…

Eli Lilly has filed 10 patent lawsuits against wellness clinics, med spas and compounders and pharmacies for marketing and selling unapproved versions of the company’s blockbuster Type 2 diabetes drug,…

The FDA has issued two draft guidances focused on requirements for drug and biological approvals — one on formal meetings and one on alternative methods the agency may use to…

Much needs to be hammered out before the FDA can comfortably green light first-in-human studies of artificial womb devices for extremely premature infants, said several members of the FDA’s Pediatric…

The FDA has expanded the scope of its guidance on conducting clinical trials during the COVID-19 pandemic to apply to public health emergencies (PHE) and other disasters, issuing final guidance…

ARS Pharmaceuticals announced that the FDA issued a complete response letter (CRL) on its NDA for neffy (epinephrine nasal spray) after having received a recommendation for approval from the agency’s…

CDRH, as part of its MDUFA V commitments, has released a draft plan to further its work toward globally harmonized medical device regulation, policy and practices as part of the…

Despite impressive gains in recent years, investment in gene therapy products is at a critical juncture due to current manufacturing challenges, among other factors, says Peter Marks, director of CBER,…